Duns Number:619025609
Catalog Number
NAV-038
Brand Name
Navigator Aesthetic Delivery System
Version/Model Number
NAV-038
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 04, 2017
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
95ad600f-c0ec-4c39-817d-941da9761bd7
Public Version Date
March 17, 2020
Public Version Number
3
DI Record Publish Date
February 24, 2017
Package DI Number
00851634007022
Quantity per Package
25
Contains DI Package
00851634007015
Package Discontinue Date
November 04, 2017
Package Status
Not in Commercial Distribution
Package Type
Case of 25
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 3 |